What are examples of research involving human specimens, cells, cell lines, or data that would not be considered human subjects research under HHS regulations at 45 CFR Part 46?
Research that proposes the use of only cadaver specimens is not human subjects research, because, by definition, human subjects must be “living individuals.” Research involving cadaver specimens, therefore, is not regulated by 45 CFR Part 46, but may be governed by other Federal, state and local laws. Research that proposes the use of human cell lines available from the American Type Culture Collection or a similar repository is not considered human subjects research because the cells are publicly available and all of the information known about the cell lines (perhaps, including the donor) is also publicly available. Research that proposes the use of established cells from a donor whose identity cannot be readily ascertained by the investigator is not considered to be human subjects research, either, for example, because there are written IRB-approved policies and procedures prohibiting release of identifiers or an agreement specifying that identifying information will not be shared w
Related Questions
- What are examples of research involving human specimens, cells, cell lines, or data that would not be considered human subjects research under HHS regulations at 45 CFR Part 46?
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